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510(k)s Final Decisions Rendered for December 2001 |
SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE) 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD 01-DEC-2001 THROUGH 31-DEC-2001 DEVICE: 3D LINE STEROTACTIC HARDWARE ACCESSORIES 3D LINE USA, INC. 510(k) NO: K011255(TRADITIONAL) ATTN: KAREN H RIGAMONTI PHONE NO : 410-580-1730 2807 OLD COURT ROAD SE DECISION MADE: 20-DEC-01 BALTIMORE, MD 21208 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ETHANOL ABBOTT LABORATORIES 510(k) NO: K013538(TRADITIONAL) ATTN: ALICIA SIMPSON PHONE NO : 972-518-7864 1920 HURD DRIVE, MS 8-21 SE DECISION MADE: 14-DEC-01 IRVING, TX 75038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: H/S ELLIPTOSPHERE CATHETER SET, MODEL 61-4005 ACKARD LABORATORIES 510(k) NO: K013972(SPECIAL) ATTN: RICHARD HETTENBACH PHONE NO : 908-276-6290 70 JACKSON DR. SE DECISION MADE: 17-DEC-01 P.O. BOX 1085 510(k) SUMMARY AVAILABLE FROM FDA CRANFORD, NJ 07016 DEVICE: ACON MOP ONE STEP OPIATE TEST STRIP, ACON MOP STEP OPIATE TEST D ACON LABORATORIES, INC. 510(k) NO: K013380(TRADITIONAL) ATTN: EDWARD TUNG PHONE NO : 858-535-2030 4108 SORRENTO VALLEY BLVD. SE DECISION MADE: 18-DEC-01 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POLARUS CAP SCREW ACUMED, INC. 510(k) NO: K013616(TRADITIONAL) ATTN: SHARI JEFFERS PHONE NO : 503-627-9957 10950 S.W. 5TH ST., SUITE 170 SE DECISION MADE: 19-DEC-01 BEAVERTON, OR 97005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DURAPRENE STERILE SYNTHETIC POWDER-FREE SURGICAL GLOVES WITH TES ALLEGIANCE HEALTHCARE CORP. 510(k) NO: K013302(TRADITIONAL) ATTN: ERICA SETHI PHONE NO : 847-785-3337 1500 WAUKEGAN RD. BLDG. WM SE DECISION MADE: 17-DEC-01 MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPROCESSED SOFT TISSUE ABLATORS ALLIANCE MEDICAL CORP. 510(k) NO: K012631(TRADITIONAL) ATTN: DON SELVEY PHONE NO : 480-763-5300 10232 SOUTH 51ST ST. SE DECISION MADE: 06-DEC-01 PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO:APEX MEDICAL IF-4100 APEX MEDICAL CORP. 510(k) NO: K013813(SPECIAL) ATTN: ALAN CHANGE PHONE NO : 886 226 954170 10TH FL., NO. 31, LANE 169, SE DECISION MADE: 14-DEC-01 KANG NING ST. 510(k) STATEMENT HSI CHIH CHEN, TAIPEI HSIEN, CHINA (TAIWAN) DEVICE: REMEDY MODEL 2Z12 APOLLO CORP. 510(k) NO: K012029(TRADITIONAL) ATTN: ADRIAN SWEEN PHONE NO : 715-247-5625 450 MAIN ST. SE DECISION MADE: 31-DEC-01 SOMERSET, WI 54025 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APPLIED ACCESS SEAL APPLIED MEDICAL RESOURCES CORP. 510(k) NO: K012968(TRADITIONAL) ATTN: ANIL BHALANI PHONE NO : 949-713-8327 22872 AVENIDA EMPRESSA SE DECISION MADE: 03-DEC-01 RANCHO SANTA MARGARITA, CA 92688 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FILTERFLO H ARC MEDICAL, INC. 510(k) NO: K011212(TRADITIONAL) ATTN: HAL NORRIS PHONE NO : 800-950-2720 322 PATTERSON AVE. SE DECISION MADE: 20-DEC-01 SCOTTDALE, GA 30079 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLUE LATEX EXAMINATION GLOVES, POWDER FREE ARISTA LATINDO INDUSTRIAL, LTD. P.510(k) NO: K013320(TRADITIONAL) ATTN: LINGA SUMARTA PHONE NO : 622 166 20201195 128 JALAN KYAI HAJI MUHAMMAD SE DECISION MADE: 19-DEC-01 MANSYUR 510(k) STATEMENT JAKARTA BARAT, INDONESIA 11210 DEVICE: ENDOFLIP ATLANTECH MEDICAL DEVICES LTD. 510(k) NO: K013334(TRADITIONAL) ATTN: NICK WOODS PHONE NO : 44 142 3888806 38 FREEMANS WAY SE DECISION MADE: 13-DEC-01 HARROGATE, NORTH YORKSHIRE, UNITED510(k) STATEMENT DEVICE: AUTOGENESIS AUTOMATOR, MODEL M1000 AUTOGENESIS, INC. 510(k) NO: K013818(SPECIAL) ATTN: JAMES EDWARDS PHONE NO : 410-665-2017 8700 OLD HARFORD RD. SE DECISION MADE: 05-DEC-01 BALTIMORE, MD 21234 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AVID-NIT PLASTIC HUB LUTZ EPIDURAL NEEDLE,MODEL RP2035L, AVID-NI AVID N.I.T., INC. 510(k) NO: K013231(TRADITIONAL) ATTN: SCOTT HENDERSON PHONE NO : 813-818-8705 390 SCARLET BLVD. SE DECISION MADE: 03-DEC-01 OLDSMAR, FL 34677 510(k) STATEMENT DEVICE: HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C BAXTER HEALTHCARE CORP. 510(k) NO: K012988(TRADITIONAL) ATTN: DAVID E CURTIN PHONE NO : 847-473-6079 1620 WAUKEGAN RD. SE DECISION MADE: 05-DEC-01 MPGR-A2E 510(k) SUMMARY AVAILABLE FROM FDA MCGAW PARK, IL 60085 DEVICE: BAYER ADVIA IMS SYSTEM; C-REACTIVE PROTEIN SYSTEM BAYER CORP. 510(k) NO: K012337(TRADITIONAL) ATTN: KENNETH T EDDS PHONE NO : 914-524-2446 511 BENEDICT AVE. SE DECISION MADE: 06-DEC-01 TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM BAYER CORP. 510(k) NO: K013568(TRADITIONAL) ATTN: KENNETH T EDDS PHONE NO : 914-524-2446 511 BENEDICT AVE. SE DECISION MADE: 21-DEC-01 TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGG ASSAY BAYER DIAGNOSTICS CORP. 510(k) NO: K012183(TRADITIONAL) ATTN: BARBARA PREISEL-SIMMONS PHONE NO : 508-359-7711 63 NORTH STREET SE DECISION MADE: 27-DEC-01 MEDFIELD, MA 02052 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVIA CENTAUR HOMOCYSTEINE ASSAY BAYER DIAGNOSTICS CORP. 510(k) NO: K013406(TRADITIONAL) ATTN: KENNETH T EDDS PHONE NO : 914-524-2446 511 BENEDICT AVE SE DECISION MADE: 18-DEC-01 TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACS 180 HOMOCYSTEINE ASSAY BAYER DIAGNOSTICS CORP. 510(k) NO: K013606(TRADITIONAL) ATTN: KENNETH T EDDS PHONE NO : 914-524-2446 511 BENEDICT AVE SE DECISION MADE: 21-DEC-01 TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNCHRON SYSTEMS VANCOMYCIN REAGENT; SYNCHRON SYSTEMS VANCOMYCIN BECKMAN COULTER, INC. 510(k) NO: K013076(TRADITIONAL) ATTN: MARY BETH TANG PHONE NO : 714-961-3777 200 SOUTH KRAEMER BLVD.,W-104 SE DECISION MADE: 12-DEC-01 BREA, CA 92822-8000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMMUNO-TROL LOW CELLS BECKMAN COULTER, INC. 510(k) NO: K013842(TRADITIONAL) ATTN: LOURDES COBA PHONE NO : 305-380-4079 11800 SW 147TH AVENUE SE DECISION MADE: 13-DEC-01 MIAMI, FL 33196-2500 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND BECKMAN COULTER, INC. 510(k) NO: K014034(SPECIAL) ATTN: ANNETTE HELLIE PHONE NO : 714-993-8767 200 SOUTH KRAEMER BLVD. SE DECISION MADE: 18-DEC-01 BREA, CA 92822 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGU BECTON DICKINSON INFUSION THERAPY 510(k) NO: K013800(TRADITIONAL) ATTN: LESLIE WOOD PHONE NO : 801-565-2504 9450 SOUTH STATE ST. SE DECISION MADE: 21-DEC-01 SANDY, UT 84070 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE BIOLITEC, INC. 510(k) NO: K013193(TRADITIONAL) ATTN: CAROL J MORELLO PHONE NO : 413-525-0600 515 SHAKER ROAD SE DECISION MADE: 21-DEC-01 EAST LONGMEADOW, MA 01028 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RESORBABLE NO PROFILE SCREW AND WASHER BIOMET MANUFACTURING, INC. 510(k) NO: K012469(TRADITIONAL) ATTN: SARA B SHULTZ PHONE NO : 219-267-6639 P.O. BOX 587 SE DECISION MADE: 03-DEC-01 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SELF-COUNTERSINKING BONE SCREW BIOMET ORTHOPEDICS, , INC. 510(k) NO: K013534(TRADITIONAL) ATTN: SARA B SHULTZ PHONE NO : 219-267-6639 P.O. BOX 587 SE DECISION MADE: 17-DEC-01 WARSAW, IN 46582 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO: BIOMET HUMERAL CABLE PLATES BIOMET ORTHOPEDICS, , INC. 510(k) NO: K013657(SPECIAL) ATTN: TRACY J BICKEL PHONE NO : 219-267-6639 P.O. BOX 587 SE DECISION MADE: 03-DEC-01 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LORENZ LACTOSORB PANELS AND FASTENERS BIOMET, INC. 510(k) NO: K011139(TRADITIONAL) ATTN: TRACY J BICKEL PHONE NO : 219-372-1761 AIRPORT INDUSTRIAL PARK SE DECISION MADE: 20-DEC-01 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: REUNITE FUSION SCREW BIOMET, INC. 510(k) NO: K011451(TRADITIONAL) ATTN: SARA BAILEY SHULTZ PHONE NO : 219-372-1568 P.O. BOX 587 SE DECISION MADE: 10-DEC-01 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO: INJECTABLE MIMIX BIOMET, INC. 510(k) NO: K012569(SPECIAL) ATTN: SARA B SHULTZ PHONE NO : 219-267-6639 56 EAST BELL DRIVE SE DECISION MADE: 21-DEC-01 PO BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46582 DEVICE: SOFT TISSUE SCREW AND WASHER BIOMET, INC. 510(k) NO: K012572(TRADITIONAL) ATTN: SARA B SHULTZ PHONE NO : 219-267-6639 56 EAST BELL DRIVE SE DECISION MADE: 03-DEC-01 PO BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0578 DEVICE: GENERATION 4 BONE CEMENT BIOMET, INC. 510(k) NO: K993836(TRADITIONAL) ATTN: MARY VERSTYNEN PHONE NO : 219-267-6639 AIRPORT INDUSTRIAL PARK SE DECISION MADE: 19-DEC-01 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM BIOPLATE, INC. 510(k) NO: K013050(TRADITIONAL) ATTN: CAROL E JONES PHONE NO : 323-549-9500 6911 MELROSE AVE. SE DECISION MADE: 10-DEC-01 LOS ANGELES, CA 90038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM BIOPLATE, INC. 510(k) NO: K013055(TRADITIONAL) ATTN: CAROL E JONES PHONE NO : 323-549-9500 6911 MELROSE AVE. SE DECISION MADE: 07-DEC-01 LOS ANGELES, CA 90038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOTEQUE VAGINAL PESSARIES BIOTEQUE AMERICA, INC. 510(k) NO: K013289(TRADITIONAL) ATTN: DENIS DORSEY PHONE NO : 215-750-8071 340 EAST MAPLE AVE., #204-C SE DECISION MADE: 27-DEC-01 LANGHORNE, PA 19047 510(k) STATEMENT DEVICE: ASMOTOM AUTOMATED TREPHINE SYSTEM BKG OPTHALMICS USA, INC. 510(k) NO: K013151(TRADITIONAL) ATTN: ART WARD PHONE NO : 813-645-2855 962 ALLEGRO LANE SE DECISION MADE: 14-DEC-01 APOLLO BEACH, FL 33572 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MULTITAK SUTURE SNAP SYSTEM BONUTTI RESEARCH, INC. 510(k) NO: K013177(TRADITIONAL) ATTN: PATRICK BALSMANN PHONE NO : 217-342-3412 2600 SOUTH RANEY SE DECISION MADE: 19-DEC-01 P.O. BOX 1367 510(k) SUMMARY AVAILABLE FROM FDA EFFINGHAM, IL 62401 DEVICE: CONVOY ADVANCED DELIVERY SHEATH KIT BOSTON SCIENTIFIC 510(k) NO: K013866(SPECIAL) ATTN: ANDREA L RUTH PHONE NO : 408-895-3625 2710 ORCHARD PARKWAY SE DECISION MADE: 14-DEC-01 SAN JOSE, CA 95134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRA -THIN SDS BALLOON DILATATION CATHETER BOSTON SCIENTIFIC CORP. 510(k) NO: K011889(TRADITIONAL) ATTN: JENNIFER BOLTON PHONE NO : 508-652-5972 ONE BOSTON SCIENTIFIC PLACE SE DECISION MADE: 21-DEC-01 NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181, 16 BOSTON SCIENTIFIC, TARGET 510(k) NO: K013789(SPECIAL) ATTN: GEORGE J PRENDERGAST PHONE NO : 510-440-7604 47900 BAYSIDE PARKWAY SE DECISION MADE: 06-DEC-01 FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PAIN CARE 3200 BREG, INC. 510(k) NO: K013928(SPECIAL) ATTN: KATHLEEN BARBER PHONE NO : 760-599-3000 2611 COMMERCE WAY SE DECISION MADE: 03-DEC-01 VISTA, CA 92083 510(k) STATEMENT DEVICE: CORLINK AAD (3.5 TO 6.0 M M OUTER DIAMETER VESSELS),MODEL 200-06 BYPASS LTD. 510(k) NO: K011589(TRADITIONAL) ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5910 555 THIRTEENTH STREET NW SE DECISION MADE: 26-DEC-01 WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAIRD TECHNOLOGY HOLTER 2000 CAIRD TECHNOLOGY 510(k) NO: K012686(TRADITIONAL) ATTN: JAMES H BROWN PHONE NO : 803-736-1289 205 CAMDEN CHASE SE DECISION MADE: 13-DEC-01 COLUMBIA, SC 29223 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPIRIT 300 CAIRE, INC. 510(k) NO: K013251(TRADITIONAL) ATTN: ROGER BRIESE PHONE NO : 952-882-5071 3505 COUNTY RD. 42 WEST SE DECISION MADE: 18-DEC-01 BURNSVILLE, MN 55306-3803 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: INVERNESS MEDICAL EARLY PREGNANCY TEST CAMBRIDGE DIAGNOSTICS IRELAND, LTD510(k) NO: K013907(SPECIAL) ATTN: AVRIL MURRAY PHONE NO : 011 353 91757534 MERVUE BUSINESS PARK SE DECISION MADE: 18-DEC-01 GALWAY, IRELAND 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROJET QUARK, MODEL U100 OR U40 CANE SRL 510(k) NO: K013807(TRADITIONAL) ATTN: DANIEL KAMM PHONE NO : 847-374-1727 P.O. BOX 7007 SE DECISION MADE: 12-DEC-01 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR CANOPUS MEDICAL SUPPLY CO., LTD. 510(k) NO: K013753(TRADITIONAL) ATTN: ELIZABETH DENG PHONE NO : 909-465-9188 13808 MAGNOLIA AVE. SE DECISION MADE: 10-DEC-01 CHINO, CA 91710 510(k) STATEMENT DEVICE: "DATACAPTOR" CAPSULE TECHNOLOGIE 510(k) NO: K013019(TRADITIONAL) ATTN: DANIEL KAMM PHONE NO : 847-374-1727 PO BOX 7007 SE DECISION MADE: 18-DEC-01 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MALLEABLE SURGICAL LIGHTSTIC 180, MODEL 180 (1CM-9CM) CARDIOFOCUS, INC. 510(k) NO: K013901(SPECIAL) ATTN: JOSEPH CURTIS PHONE NO : 508-285-1700 10 COMMERCE WAY SE DECISION MADE: 20-DEC-01 NORTON, MA 02766 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOLO-CARE PLUS MULTIPURPOSE SOLUTION CIBA VISION CORP. 510(k) NO: K012731(TRADITIONAL) ATTN: STEVEN DOWDLEY PHONE NO : 687-415-3897 11460 JOHNS CREEK PKWY. SE DECISION MADE: 26-DEC-01 DULUTH, GA 30097 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION CIBA VISION CORP. 510(k) NO: K013512(TRADITIONAL) ATTN: STEVEN DOWDLEY PHONE NO : 687-415-3897 11460 JOHNS CREEK PKWY. SE DECISION MADE: 20-DEC-01 DULUTH, GA 30097 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICRO-6-SERIES (MR-6, MR-6L) URETEROSCOPES, MRO-6 SERIES (MR-633 CIRCON VIDEO 510(k) NO: K011849(TRADITIONAL) ATTN: WAYNE B STERNER PHONE NO : 805-685-5100 6500 HOLLISTER AVE. SE DECISION MADE: 10-DEC-01 SANTA BARBARA, CA 93117 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHETIC POLYSIOPRENE ULTRASOUND TRANSDUCER COVER CIVCO MEDICAL INSTRUMENTS CO., INC510(k) NO: K013721(TRADITIONAL) ATTN: THERESA LEINEN PHONE NO : 319-656-4447 102 FIRST ST. SOUTH SE DECISION MADE: 28-DEC-01 KALONA, IA 52247 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPINE SCOPE, MODEL 2180 CLARUS MEDICAL, LLC. 510(k) NO: K011454(TRADITIONAL) ATTN: TOM BARTHEL PHONE NO : 763-525-8401 1000 BOONE AVE. NORTH SE DECISION MADE: 13-DEC-01 MINNEAPOLIS, MN 55427 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CODMAN SLIM-LOC SYSTEM CODMAN & SHURTLEFF, INC. 510(k) NO: K013877(SPECIAL) ATTN: KATHRYN WUNDER PHONE NO : 508-880-8351 325 PARAMOUNT DR. SE DECISION MADE: 19-DEC-01 RAYNHAM, MA 02767-0350 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNERGY FLOW COLTENE/WHALEDENT, INC. 510(k) NO: K013400(TRADITIONAL) ATTN: H.J. VOGELSTEIN PHONE NO : 201-512-8000 750 CORPORATE DR. SE DECISION MADE: 10-DEC-01 MAHWAH, NJ 07430-2009 510(k) STATEMENT DEVICE: SOCRATES ROBOTIC TELEMONITORING SYSTEM COMPUTER MOTION, INC. 510(k) NO: K013804(SPECIAL) ATTN: DAVID U THOMAS PHONE NO : 805-968-9600 130 CREMONA DRIVE, SUITE B SE DECISION MADE: 10-DEC-01 GOLETA, CA 93117 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FOCAL SIM COMPUTERIZED MEDICAL SYSTEMS, INC.510(k) NO: K013112(TRADITIONAL) ATTN: MICHAEL A PARSONS PHONE NO : 314-993-0003 1145 CORPORATE LAKE DR. SE DECISION MADE: 05-DEC-01 ST. LOUIS, MO 63132-1716 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COSMETICA (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENSES CONTACT COLOR SRL 510(k) NO: K011893(TRADITIONAL) ATTN: MARIA E DONAWA PHONE NO : 390 657 82665 VIA FONTE DI FAUNO, 22 SE DECISION MADE: 06-DEC-01 ROME, ITALY 00153 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SHAPEABLE DOPPLER FLOW PROBE COOK VASCULAR, INC. 510(k) NO: K002958(TRADITIONAL) ATTN: THOMAS J KARDOS PHONE NO : 724-845-8621 RT. 66, RIVER RD. SE DECISION MADE: 18-DEC-01 P.O. BOX 529 510(k) SUMMARY AVAILABLE FROM FDA LEECHBURG, PA 15656-0529 DEVICE: MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET COOK, INC. 510(k) NO: K013916(TRADITIONAL) ATTN: HEIDI MASTEN PHONE NO : 812-339-2235 925 SOUTH CURRY PIKE SE DECISION MADE: 20-DEC-01 P.O. BOX 489 510(k) SUMMARY AVAILABLE FROM FDA BLOOMINGTON, IN 47402 DEVICE: CSIST DICOM GATEWAY/IMAGE MANAGER CSIST 510(k) NO: K012327(TRADITIONAL) ATTN: CARL ALLETO PHONE NO : 214-262-4209 1100 LAKEVIEW BLVD. SE DECISION MADE: 20-DEC-01 DENTION, TX 76208 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CYBERMED, INC., V-WORKS CYBERMED, INC. 510(k) NO: K013878(TRADITIONAL) ATTN: GARY J ALLSEBROOK PHONE NO : 510-276-2648 16303 PANORAMIC WAY SE DECISION MADE: 07-DEC-01 SAN LEANDRO, CA 94578-1116 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MICROSCAN DRIED GRAM NEGATIVE OVERNIGHT MIC/COMBO PANELS DADE MICROSCAN, INC. 510(k) NO: K013423(TRADITIONAL) ATTN: CYNTHIA VAN DUKER PHONE NO : 916-374-3105 1584 ENTERPRISE BLVD. SE DECISION MADE: 12-DEC-01 WEST SACRAMENTO, CA 95691 510(k) STATEMENT DEVICE: DATEX-OHMEDA S/5 NETWORK AND CENTRAL '01 DATEX-OHMEDA 510(k) NO: K013246(TRADITIONAL) ATTN: JOEL KENT PHONE NO : 781-449-8685 86 PILGRIM ROAD SE DECISION MADE: 11-DEC-01 NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Z-NET DEMITE LIMITED 510(k) NO: K001003(TRADITIONAL) ATTN: WILLIAM H.E. VON OEHSEN PHONE NO : 202-347-0066 1001 PENNSYLVANIA AVE. SE DECISION MADE: 10-DEC-01 NW 6TH FLOOR 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20004 DEVICE: CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KIT DENKA SEIKEN'S 510(k) NO: K011958(TRADITIONAL) ATTN: SEIYA SATO PHONE NO : 033 669 421 3-4-2 NIHONBASHI SE DECISION MADE: 04-DEC-01 KAYABACHO, CHUO-KU 510(k) SUMMARY AVAILABLE FROM FDA TOKYO, JAPAN 103-0025 DEVICE: SUMMIT CEMENTED HIP PROSTHESIS DEPUY ORTHOPAEDICS, INC. 510(k) NO: K013352(TRADITIONAL) ATTN: MARCIA J ARENTZ PHONE NO : 219-371-4944 700 ORTHOPAEDIC DR. SE DECISION MADE: 17-DEC-01 P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0988 DEVICE: ACE BIO WIN TIBIAL NAILING SYSTEM DEPUY ORTHOPAEDICS, INC. 510(k) NO: K013430(TRADITIONAL) ATTN: MARCIA J ARENTZ PHONE NO : 219-371-4944 700 ORTHOPAEDIC DR. SE DECISION MADE: 17-DEC-01 WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LONG TROCHANTERIC NAIL SYSTEM DEPUY ORTHOPAEDICS, INC. 510(k) NO: K013563(TRADITIONAL) ATTN: MARCIA J ARENTZ PHONE NO : 219-371-4944 700 ORTHOPAEDIC DR. SE DECISION MADE: 27-DEC-01 WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DAYLITE XENON LIGHT SOURCES DESIGNS FOR VISION, INC. 510(k) NO: K013880(TRADITIONAL) ATTN: AMY GRUMET-AVALLONE PHONE NO : 631-585-3300 760 KOEHLER AVE. SE DECISION MADE: 07-DEC-01 RONKONKOMA, NY 11779 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: DC-UIBC-CO2-CAL, MODEL SE-153 DIAGNOSTIC CHEMICALS LTD. 510(k) NO: K013178(TRADITIONAL) ATTN: NANCY OLSCAMP PHONE NO : 902 566 1396 16 MCCARVILLE STREET SE DECISION MADE: 18-DEC-01 CHARLOTTETOWN, CANADA C1E 2A6 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM DIAMEDIX CORP. 510(k) NO: K013628(TRADITIONAL) ATTN: LYNNE STIRLING PHONE NO : 305-324-2354 2140 NORTH MIAMI AVE. SE DECISION MADE: 21-DEC-01 MIAMI, FL 33127 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STANDARD A, STANDARD B, STANDARD C, CAL, SLOPE DIAMOND DIAGNOSTICS, INC. 510(k) NO: K013850(TRADITIONAL) ATTN: LINDA M STUNDTNER PHONE NO : 508-429-0450 331 FISKE STREET SE DECISION MADE: 21-DEC-01 HOLLISTON, MA 01746 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO FIXION INTERLOCKING INTRAMEDULLARY NAILING SYSTE DISC-O-TECH MEDICAL TECHNOLOGIES, 510(k) NO: K013449(TRADITIONAL) ATTN: ELAD MAGAL PHONE NO : 972 9 9511511 3 HASADNAOT SE DECISION MADE: 19-DEC-01 HERZELIA, ISRAEL 46728 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DRG ORTHOHEX SS BONE SCREW DOCTOR'S RESEARCH GROUP, INC. 510(k) NO: K013786(TRADITIONAL) ATTN: RICHARD DESLAURIERS PHONE NO : 860-283-1479 50 ALTAIR AVENUE SE DECISION MADE: 17-DEC-01 PLYMOUTH, CT 06782 510(k) STATEMENT DEVICE: DXS DIGITAL X-RAY SYSTEM DOUGLAS C. YOON, DDS 510(k) NO: K013271(TRADITIONAL) ATTN: DOUGLAS C YOON PHONE NO : 310-702-3185 3940 LAUREL CANYON BLVD. #147 SE DECISION MADE: 13-DEC-01 STUDIO CITY, CA 91604 510(k) STATEMENT DEVICE: OXYLOG 1000, MODEL 2M86840 DRAGER MEDIZINTECHNIK GMBH 510(k) NO: K010793(TRADITIONAL) ATTN: JAMES J BRENNAN PHONE NO : 215-721-5400 3135 QUARRY ROAD SE DECISION MADE: 20-DEC-01 TELFORD, PA 18969 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NO STEP ON SITE DEUG TEST CUP DRUG FREE ENTERPRISES 510(k) NO: K012390(TRADITIONAL) ATTN: PERRY RUCKER PHONE NO : 310-415-7093 1627 S GRANVILLE AVE. SUITE 3 SE DECISION MADE: 18-DEC-01 WEST LOS ANGELES, CA 90025 510(k) STATEMENT DEVICE: KODAK DIRECTVIEW TABLETOP CASSETTE EASTMAN KODAK COMPANY 510(k) NO: K013686(SPECIAL) ATTN: JUDITH A WALLACE PHONE NO : 716-724-6111 1669 LAKE AVE. SE DECISION MADE: 07-DEC-01 ROCHESTER, NY 14652 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO EBI XFIX DFS SYSTEM EBI, L.P. 510(k) NO: K013739(SPECIAL) ATTN: FREDERIC TESTA PHONE NO : 973-299-9300 100 INTERPACE PKWY. SE DECISION MADE: 13-DEC-01 PARSIPPANY, NJ 07054-1079 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO THE GRIP ELCARE INNOVATIONS, INC. 510(k) NO: K010526(TRADITIONAL) ATTN: ELROY T CANTRELL PHONE NO : 817-483-2310 7101 STEPHENSON-LEVEY RD SE DECISION MADE: 13-DEC-01 BURLESON, TX 76028 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO LEKSELL SURGIPLAN WITH ATLASPACE ELEKTA INSTRUMENT AB 510(k) NO: K013861(SPECIAL) ATTN: CAROL PATTERSON PHONE NO : 949-462-0900 21911 ERIE LANE SE DECISION MADE: 06-DEC-01 LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PLASMA SPRAYED SHOULDER ENCORE ORTHOPEDICS, INC. 510(k) NO: K003324(TRADITIONAL) ATTN: JOANNA DROEGE PHONE NO : 512-834-6255 9800 METRIC BLVD. SE DECISION MADE: 06-DEC-01 AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROMARK II TISSUE MARKER,MODEL C1535 ETHICON ENDO-SURGERY, INC. 510(k) NO: K013413(TRADITIONAL) ATTN: GEORGIA C ABERNATHY PHONE NO : 513-337-3179 4545 CREEK RD. SE DECISION MADE: 03-DEC-01 CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INDIGO OPTIMA LASER SYSTEM ETHICON ENDO-SURGERY, INC. 510(k) NO: K013493(TRADITIONAL) ATTN: LINDA HILL PHONE NO : 513-337-7623 4545 CREEK ROAD SE DECISION MADE: 13-DEC-01 CINCINNATI, OH 45242 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT EVENFLO COMPANY, INC. 510(k) NO: K013226(TRADITIONAL) ATTN: MATTHEW G MCCARTY PHONE NO : 770-704-2000 1000 EVENFLO DRIVE SE DECISION MADE: 20-DEC-01 P.O. BOX 709 510(k) STATEMENT CANTON, GA 30114 DEVICE: MODIFICATION TO: ACUMATCH L-SERIES BIPOLAR ENDOPROSTHESIS EXACTECH, INC. 510(k) NO: K013211(SPECIAL) ATTN: ROBERT PAXSON PHONE NO : 352-377-1140 2320 N.W. 66TH CT. SE DECISION MADE: 05-DEC-01 GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXCEL A.V FISUTAL NEEDLE SET EXELINT INTL. CO. 510(k) NO: K013037(TRADITIONAL) ATTN: ARMAND HAMID PHONE NO : 310-649-0707 5840 WEST CENTINELA AVE. SE DECISION MADE: 07-DEC-01 LOS ANGELES, CA 90045 510(k) STATEMENT DEVICE: BI-3M NEEDLE-FREE INJECTOR SYSTEM FELTON INTERNATIONAL, INC. 510(k) NO: K013256(TRADITIONAL) ATTN: ALAN FELTON PHONE NO : 913-599-1590 8210 MARSHALL DRIVE SE DECISION MADE: 07-DEC-01 LENEXA, KS 66214 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO ALPHA DX SYSTEM FIRST MEDICAL, INC. 510(k) NO: K014024(SPECIAL) ATTN: GREG HOLLAND PHONE NO : 949-262-0411 3722 AVE. SAUSALITO SE DECISION MADE: 18-DEC-01 IRVINE, CA 92606 510(k) STATEMENT DEVICE: OSPREY SPHERICAL AND TORIC MULTIFOCAL SOFT CONTACT LENSES FLORIDA OPTICAL ENGINEERING, INC. 510(k) NO: K013445(TRADITIONAL) ATTN: RICHARD A GRIFFIN PHONE NO : 386-472-2710 13709 PROGRESS BLVD., BOX 14 SE DECISION MADE: 26-DEC-01 ALACHUA, FL 32615 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FOTONA DUALIS, FOTONA DUALIS PLUS FOTONA D.D. 510(k) NO: K011939(TRADITIONAL) ATTN: MOJCA VALJAVEC PHONE NO : 386 151 11215 STEGNE 7, SE DECISION MADE: 27-DEC-01 LJUBLJANA, SLOVENIA 1210 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FUJI SPEED SUITE, FUJI SPEED SUTE PHASE II FUJIFILM MEDICAL SYSTEM U.S.A., IN510(k) NO: K013218(ABBREVIATED) ATTN: JOSEPH M AZARY PHONE NO : 203-327-6485 419 WEST AVE. SE DECISION MADE: 20-DEC-01 STAMFORD, CT 06902 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FUKUDA DENSHI MODEL HG-500, PULSE OXIMETER MODULE FUKUDA DENSHI USA, INC. 510(k) NO: K013273(TRADITIONAL) ATTN: LARRY WALKER PHONE NO : 425-881-7737 17725 N.E. 65TH ST., BLDG. C SE DECISION MADE: 20-DEC-01 REDMOND, WA 98052-4911 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENTEGRA PE PERSONAL DIGITAL ASSISTANT GENERAL ELECTRIC MEDICAL SYSTEMS 510(k) NO: K014058(TRADITIONAL) ATTN: D. DUERSTELER PHONE NO : 262-317-9463 3000 NORTH GRANDVIEW BLVD. SE DECISION MADE: 21-DEC-01 WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: GIMMI'ALPHA' ENDOSCOPES & ACCESSORIES GIMMI GMBH 510(k) NO: K012660(ABBREVIATED) ATTN: DAGMAR MASER PHONE NO : 312 042 89591 AMSTEL 320-I SE DECISION MADE: 20-DEC-01 AMSTERDAM, NETHERLANDS 1017AP 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GLUSITE, MODEL GLU002 GLUSTITCH, INC. 510(k) NO: K013446(TRADITIONAL) ATTN: DON BLACKLOCK PHONE NO : 800 667 2130 #307 7188 PROGRESS WAY SE DECISION MADE: 20-DEC-01 DELTA, B.C., CANADA V4G 1M6 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMPANION MODEL 221, 321, 421 GOLDEN TECHNOLOGIES, INC. 510(k) NO: K012258(TRADITIONAL) ATTN: FRED KIWAK PHONE NO : 570-451-7477 401 BRIDGE ST. SE DECISION MADE: 03-DEC-01 OLD FORGE, PA 18518 510(k) STATEMENT DEVICE: HI-TOQUE WHISPER LS AND MS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC GUIDANT CORP. 510(k) NO: K013092(TRADITIONAL) ATTN: JENNIFER P RIGGS PHONE NO : 909-914-4581 26531 YNEZ RD. SE DECISION MADE: 13-DEC-01 TEMECULA, CA 92591-4628 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO VIKING OPTIMA GUIDING CATHETER GUIDANT CORP. 510(k) NO: K013638(SPECIAL) ATTN: NANCY E RALSTON PHONE NO : 909-914-6654 26531 YNEZ RD. SE DECISION MADE: 04-DEC-01 TEMECULA, CA 92591-4628 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOSPEED H.S. HOSPITAL SERVICES S.P.A. 510(k) NO: K013069(TRADITIONAL) ATTN: LUCIO IMPROTA PHONE NO : 561-477-1671 10147 UMBERLAND PLACE SE DECISION MADE: 12-DEC-01 BOCA RATON, FL 33428 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JAMSHIDI BIOPSY NEEDLE H.S. HOSPITAL SERVICES S.P.A. 510(k) NO: K013070(TRADITIONAL) ATTN: LUCIO IMPROTA PHONE NO : 561-477-1671 10147 UMBERLAND PLACE SE DECISION MADE: 12-DEC-01 BOCA RATON, FL 33428 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SECURCUT ASPIRATION BIOPSY NEEDLE H.S. HOSPITAL SERVICES S.P.A. 510(k) NO: K013071(TRADITIONAL) ATTN: LUCIO IMPROTA PHONE NO : 561-477-1671 10147 UMBERLAND PLACE SE DECISION MADE: 12-DEC-01 BOCA RATON, FL 33428 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTRAMEDULLARY FIXATION SYSTEM FOR THE HAND HAND INNOVATIONS, INC. 510(k) NO: K013424(TRADITIONAL) ATTN: AL WEISENBORN PHONE NO : 305-829-3437 8905 SW 87TH AVENUE SE DECISION MADE: 20-DEC-01 MIAMI, FL 33176-2227 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343 HELENA LABORATORIES 510(k) NO: K013466(TRADITIONAL) ATTN: PATRICIA FRANKS PHONE NO : 409-842-3714 P.O. BOX 752 SE DECISION MADE: 21-DEC-01 1530 LINDBERGH DRIVE 510(k) STATEMENT BEAUMONT, TX 77794 DEVICE: ACUGLIDE BRAND ACUPUNCTURE NEEDLES HELIO MEDICAL SUPPLIES, INC. 510(k) NO: K012583(TRADITIONAL) ATTN: YI FEN CHANG PHONE NO : 408-433-3355 606 CHARCOT AVE. SE DECISION MADE: 11-DEC-01 SAN JOSE, CA 95131 510(k) STATEMENT DEVICE: STRESS GUARD, MODEL HERDEV1 HERBO MEDEX INTERNATIONAL, INC. 510(k) NO: K004008(TRADITIONAL) ATTN: RICHARD KEEN PHONE NO : 203-329-2700 1151 HOPE STREET SE DECISION MADE: 13-DEC-01 STAMFORD, CT 06907 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROGYN PLUS STIMULATION DEVICE HOLLISTER, INC. 510(k) NO: K013141(TRADITIONAL) ATTN: JOSEPH S TOKARZ PHONE NO : 847-680-2849 2000 HOLLISTER DR. SE DECISION MADE: 19-DEC-01 LIBERTYVILLE, IL 60048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM HOWMEDICA OSTEONICS 510(k) NO: K013772(SPECIAL) ATTN: KAREN ARIEMMA PHONE NO : 201-825-4900 59 ROUTE 17 SE DECISION MADE: 03-DEC-01 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRIDENT POROUS TITANIUM ACETABULAR COMPONENT WITH PERI-APATITE C HOWMEDICA OSTEONICS CORP. 510(k) NO: K013475(TRADITIONAL) ATTN: MARGARET F CROWE PHONE NO : 201-934-4359 59 ROUTE 17 SE DECISION MADE: 20-DEC-01 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRIDENT HEMISPHERICAL ACETABULAR SHELLS HOWMEDICA OSTEONICS CORP. 510(k) NO: K013676(SPECIAL) ATTN: JENNIFER A DAUDELIN PHONE NO : 201-934-4354 59 ROUTE 17 SE DECISION MADE: 05-DEC-01 ALLENDALE, NJ 07070-2584 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO XIA SPINAL SYSTEM HOWMEDICA OSTEONICS CORP. 510(k) NO: K013688(SPECIAL) ATTN: KAREN ARIEMMA PHONE NO : 201-825-4900 59 ROUTE 17 SE DECISION MADE: 05-DEC-01 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XIA SPINAL SYSTEM HOWMEDICA OSTEONICS CORP. 510(k) NO: K013823(SPECIAL) ATTN: KAREN ARIEMMA PHONE NO : 201-760-8187 59 ROUTE 17 SE DECISION MADE: 19-DEC-01 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGICAP HUMANA USA, INC. 510(k) NO: K012199(TRADITIONAL) ATTN: H.N. DUNNING PHONE NO : 301-229-2138 8309 BRYANT DRIVE SE DECISION MADE: 19-DEC-01 BETHESDA, MD 20817 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: H.M.T. ACUPUNCTURE NEEDLE HUMMINGBIRD MEDICAL TECHNOLOGY, L.510(k) NO: K012501(TRADITIONAL) ATTN: GEOFFREY HSU PHONE NO : 214-284-5433 1427 GREENBRIAR DR. SE DECISION MADE: 11-DEC-01 ALLEN, TX 75013 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ICS MEDICAL MODEL VG-30 VIDEO GOGGLES ICS MEDICAL 510(k) NO: K013060(TRADITIONAL) ATTN: ROBERT M SIMENSON PHONE NO : 800-289-2150 125 COMMERCE DR. SE DECISION MADE: 10-DEC-01 SCHAUMBURG, IL 60173-5329 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM IMAGYN MEDICAL TECHNOLOGIES, INC. 510(k) NO: K010166(TRADITIONAL) ATTN: JULIE POWELL PHONE NO : 616-629-2787 8850 M-89 SE DECISION MADE: 03-DEC-01 RICHLAND, MI 49083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSSEOTITE DENTAL IMPLANTS IMPLANT INNOVATIONS, INC. 510(k) NO: K013570(SPECIAL) ATTN: JACQUELYN A HUGHES PHONE NO : 561-776-6819 4555 RIVERSIDE DR. SE DECISION MADE: 17-DEC-01 PALM BEACH GARDENS, FL 33410 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HOME-AWAY SYSTEM IN-X CORP. 510(k) NO: K004047(TRADITIONAL) ATTN: CHARLIE HENRY PHONE NO : 303-574-3115 6753 EAST 47TH AVENUE SE DECISION MADE: 18-DEC-01 UNIT D 510(k) SUMMARY AVAILABLE FROM FDA DENVER, CO 80216 DEVICE: LATEX EXAMINATION GLOVES POWDERFREE POLYMER COATED WITH PROTEIN INNOVATIVE GLOVES CO; LTD 510(k) NO: K013333(TRADITIONAL) ATTN: RAJEEV K SOOD PHONE NO : 661 897 9821 11 CHOTEVITTAYAKUL 3 RD. SE DECISION MADE: 07-DEC-01 HATYAI, SONGKHLA, THAILAND 510(k) STATEMENT DEVICE: INVACARE ELEVATING SEAT OPTION ESS6 INVACARE CORP. 510(k) NO: K013516(TRADITIONAL) ATTN: RAE A FARROW PHONE NO : 440-329-6356 ONE INVACARE WAY SE DECISION MADE: 13-DEC-01 P.O. BOX 4028 510(k) SUMMARY AVAILABLE FROM FDA ELYRIA, OH 44036-2125 DEVICE: MEDIGROUP KEY TUBE JANIN GROUP, INC. 510(k) NO: K013017(TRADITIONAL) ATTN: JOHN A NAVIS PHONE NO : 630-428-4143 505 WESTON RIDGE DR. SE DECISION MADE: 06-DEC-01 NAPERVILLE, IL 60563-3932 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AST (SGOT) JAS DIAGNOSTIC, INC. 510(k) NO: K013698(TRADITIONAL) ATTN: DAVID JOHNSTON PHONE NO : 305-418-2320 7220 NW 58TH ST. SE DECISION MADE: 21-DEC-01 MIAMI, FL 33166 510(k) STATEMENT DEVICE: JOSTRA FLOWPROBE FP-32E JOSTRA AG 510(k) NO: K013939(TRADITIONAL) ATTN: KATHLEEN JOHNSON PHONE NO : 610-932-7738 478 MEDIA ROAD SE DECISION MADE: 14-DEC-01 OXFORD, PA 19363 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: K-SYSTEMS CULTURE BAG SEALER AND CULTURE BAGS TYPE CBS-1 AND CB- K-SYSTEMS, KIVEX BIOTEC LTD. 510(k) NO: K013401(TRADITIONAL) ATTN: JACOB MOLLENBACH PHONE NO : 454 599 5600 KLINTEHOJ VAENGE 21 SE DECISION MADE: 14-DEC-01 BIRKEROD, DENMARK DA-3460 510(k) STATEMENT DEVICE: KIMSTIM AURICULAR ELECTRODE KIM INSTITUTE FOR REHABILITATION M510(k) NO: K011691(TRADITIONAL) ATTN: DONALD F GRABARZ PHONE NO : 801-233-0075 7651 S. 700 WEST SE DECISION MADE: 27-DEC-01 SUITE 105 510(k) STATEMENT SALT LAKE CITY, UT 84047 DEVICE: ROYAL IMPERIAL POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CO KOON SENG SDN.BHD 510(k) NO: K013537(TRADITIONAL) ATTN: LIM WENG HENG PHONE NO : 606 986 8446 PTD 3274 BATU 4 1/2 SE DECISION MADE: 07-DEC-01 JALAN BAKRI 510(k) STATEMENT MUAR JOHOR, MALAYSIA 84200 DEVICE: LARES RESEARCH SUNLASE 800P LASER SYSTEM (TO BE SOLD AS "POCKETP LARES RESEARCH, INC. 510(k) NO: K011960(TRADITIONAL) ATTN: THOMAS H LOUISELL PHONE NO : 530-345-1767 295 LOCKHEED AVE. SE DECISION MADE: 21-DEC-01 CHICO, CA 95973 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRE-LOADED ULTRAFIX RC LINVATEC CORP. 510(k) NO: K013553(TRADITIONAL) ATTN: LAURA D SENEFF PHONE NO : 727-399-5234 11311 CONCEPT BLVD. SE DECISION MADE: 19-DEC-01 LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIGHTSHEER UV-B PHOTOTHERAPY EQUIPMENT LUMENIS 510(k) NO: K011197(TRADITIONAL) ATTN: C. ROBERT PAYNE JR. PHONE NO : 925-249-8034 1249 QUARRY LANE SE DECISION MADE: 14-DEC-01 SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA PLEASANTON, CA 94566-3403 DEVICE: MACROPORE TS ANTI-ADHESION FILM MACROPORE, INC. 510(k) NO: K012025(TRADITIONAL) ATTN: KENNETH K KLEINHENZ PHONE NO : 858-458-0900 6740 TOP GUN ST. SE DECISION MADE: 03-DEC-01 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KNIGHTSTAR 330 VENTILATOR MALLINCKRODT, INC. 510(k) NO: K003075(TRADITIONAL) ATTN: ANTHONY MULLIN PHONE NO : 314-645-3049 675 MCDONNELL BLVD. SE DECISION MADE: 11-DEC-01 BLDG. 10-2-N 510(k) SUMMARY AVAILABLE FROM FDA ST. LOUIS, MO 63134 DEVICE: MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE MASIMO CORP. 510(k) NO: K013792(SPECIAL) ATTN: JAMES J CRONIN PHONE NO : 949-250-9688 2852 KELVIN AVE. SE DECISION MADE: 11-DEC-01 IRVINE, CA 92614-5826 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MASTER & FRANK SURGICAL GOWNS (STERILE) MASTER & FRANK ENT. CO., LTD. 510(k) NO: K012186(TRADITIONAL) ATTN: JENNIFER REICH PHONE NO : 928-773-9488 3892 SOUTH AMERICA WEST TRAIL SE DECISION MADE: 07-DEC-01 FLAGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MILLCOMP MATH RESOLUTIONS, LLC. 510(k) NO: K011845(TRADITIONAL) ATTN: WENDEL DEAN RENNER PHONE NO : 410-997-9578 5975 GALES LANE SE DECISION MADE: 04-DEC-01 COLUMBIA, MD 21045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMFORTCARE COMPRESSION SUPPORT WITIH MAGNETS AND AEGIS MICROBE MED GEN, INC. 510(k) NO: K013244(TRADITIONAL) ATTN: THEDORE BARASH PHONE NO : 561-750-1100 7284 W. PALMETTO PK. RD. SE DECISION MADE: 07-DEC-01 BOCA RATON, FL 33433-3406 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INSTACLOT FOR OTC USE, TRAUMASSTAT FOR PRESCRIPTION USE MEDAFOR, INC. 510(k) NO: K013225(TRADITIONAL) ATTN: PHILIP B JARVI PHONE NO : 763-571-6300 5201 EAST RIVER ROAD, # 312 SE DECISION MADE: 26-DEC-01 MINNEAPOLIS, MN 55421-1035 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAS LIPID CONTROL, LIQUID ASSAYED LIPID CONTROL, LEVEL 1 AND 2, MEDICAL ANALYSIS SYSTEMS, INC. 510(k) NO: K013734(SPECIAL) ATTN: PENNY M LAYMAN PHONE NO : 805-987-7891 5300 ADOLFO RD. SE DECISION MADE: 07-DEC-01 CAMARILLO, CA 93012 510(k) STATEMENT DEVICE: MODIFICATION TO MAS CARDIOLMMUNE TL; DADE CARDIAC TL MEDICAL ANALYSIS SYSTEMS, INC. 510(k) NO: K013995(TRADITIONAL) ATTN: PENNY M LAYMAN PHONE NO : 805-987-7891 5300 ADOLFO RD. SE DECISION MADE: 21-DEC-01 CAMARILLO, CA 93012 510(k) STATEMENT DEVICE: KIMAX REMOTE VIEWING STATION MEDICAL METRICS, INC. 510(k) NO: K013098(TRADITIONAL) ATTN: ANN TUNSTALL PHONE NO : 301-652-6739 4600 NORTH PARK AVE. SE DECISION MADE: 07-DEC-01 SUITE 100 510(k) STATEMENT CHEVY CHASE, MD 20815-4518 DEVICE: MSI BIPOLAR SHEATH MEDICAL SCIENTIFIC, INC. 510(k) NO: K011202(TRADITIONAL) ATTN: PAUL NARDELLA PHONE NO : 508-880-7313 125 JOHN HANCOCK RD. SE DECISION MADE: 31-DEC-01 TAUNTON, MA 02780 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDLINE EXCEL RECLINCER WHEELCHAIR MEDLINE INDUSTRIES, INC. 510(k) NO: K013761(TRADITIONAL) ATTN: ANDREA HAFERKAMP PHONE NO : 847-837-2759 ONE MEDLINE PL. SE DECISION MADE: 06-DEC-01 MUNDELEIN, IL 60060-4486 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDRAD QWIK-FIT SYRINGE MEDRAD, INC. 510(k) NO: K013815(SPECIAL) ATTN: FRANK W PELC III PHONE NO : 412-767-2400 ONE MEDRAD DR. SE DECISION MADE: 13-DEC-01 INDIANOLA, PA 15051 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDTRONIC DLP ARTERIAL CANNULA WITH 3D TIP - 22 FR. MEDTRONIC CARDIAC SURGICAL PRODUCT510(k) NO: K013013(TRADITIONAL) ATTN: ROGER W BRINK PHONE NO : 616-643-7337 620 WATSON SW SE DECISION MADE: 04-DEC-01 GRAND RAPIDS, MI 49504-6393 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GRIP LOCK ANCHOR, MODEL 411374 MEDTRONIC NEUROLOGICAL 510(k) NO: K013063(TRADITIONAL) ATTN: MONAYA LEE PHONE NO : 763-514-5068 800 53RD AVE., N.E. SE DECISION MADE: 11-DEC-01 P.O. BOX 1250 510(k) SUMMARY AVAILABLE FROM FDA MINNEAPOLIS, MN 55421 DEVICE: MEDTRONIC INVISX BURR HOLE LOCK, MODEL 60520 MEDTRONIC NEUROSURGERY 510(k) NO: K013000(TRADITIONAL) ATTN: JANET MCAULEY PHONE NO : 805-968-1546 125 CREMONA DR., SE DECISION MADE: 05-DEC-01 UNIVERSITY BUSINESS CENTER 510(k) SUMMARY AVAILABLE FROM FDA GOLETA, CA 93117 DEVICE: LIFEPAK 600 AUTOMATED EXTERNAL DEFIBRILLATOR MEDTRONIC PHYSIO-CONTROL CORP. 510(k) NO: K011144(TRADITIONAL) ATTN: SHERRI L POCOCK PHONE NO : 425-867-4332 11811 WILLOWS RD NE BX 97006 SE DECISION MADE: 03-DEC-01 REDMOND, WA 98073-9706 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPINAL MESH SYSTEM MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K011406(TRADITIONAL) ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PL. SE DECISION MADE: 27-DEC-01 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CEMENT RESTRICTOR MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K013663(SPECIAL) ATTN: RICHARD W TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PL. SE DECISION MADE: 05-DEC-01 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTE MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K013829(SPECIAL) ATTN: RICK W TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 19-DEC-01 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K014076(SPECIAL) ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PL. SE DECISION MADE: 27-DEC-01 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MENTOR CONTOUR PROFILE TISSUE EXPANDER MENTOR CORP. 510(k) NO: K011500(TRADITIONAL) ATTN: DONNA CRAWFORD PHONE NO : 805-879-6304 201 MENTOR DRIVE SE DECISION MADE: 03-DEC-01 SANTA BARBARA, CA 93111 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 5 MERITS HEALTH PRODUCTS CO., LTD. 510(k) NO: K013788(SPECIAL) ATTN: WINSTON ANDERSON PHONE NO : 800-963-7487 P.O. BOX 150356 SE DECISION MADE: 11-DEC-01 CAPE CORAL, FL 33915 510(k) STATEMENT DEVICE: AUROFLUID PLUS METALOR TECHNOLOGIES USA 510(k) NO: K013505(TRADITIONAL) ATTN: BRUCE BARTON PHONE NO : 800-554-5504 255 JOHN L. DIETSCH BLVD. SE DECISION MADE: 19-DEC-01 NORTH ATTLEBOROUGH, MA 02761 510(k) STATEMENT DEVICE: CTXA HIP; CTXA; QCT PRO CTXA HIP MINDWAYS SOFTWARE, INC. 510(k) NO: K002113(TRADITIONAL) ATTN: CHRISTOPHER CANN PHONE NO : 415-247-9930 282 SECOND ST., 4TH FL. SE DECISION MADE: 04-DEC-01 SAN FRANCISCO, CA 94105-3130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIGHT SABER INTRODUCER NEEDLE MINRAD, INC. 510(k) NO: K013040(TRADITIONAL) ATTN: HOWARD M HOLSTEIN PHONE NO : 202-637-5600 555 THIRDTEENTH ST., NW SE DECISION MADE: 07-DEC-01 WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FOTONA DUALIS ND:YAG LASER SYSTEM, FOTONA TWINLIGHT ND:YAG LASER MOJCA VALIJAVEC 510(k) NO: K013047(TRADITIONAL) ATTN: MOJCA VALJAVEC PHONE NO : FONTONA D.D SE DECISION MADE: 06-DEC-01 STEGNE 7 510(k) SUMMARY AVAILABLE FROM FDA LJUBLIJANA, SLOVENIA 1210 DEVICE: NASTECH MAMMARY ASPIRATION SPECIMAN CYTOLOGY TEST MASCT NASTECH PHARMACEUTICAL COMPANY, IN510(k) NO: K012088(TRADITIONAL) ATTN: PETER C APRILE PHONE NO : 631-273-0101 45 ADAMS AVE. SE DECISION MADE: 18-DEC-01 HAUPPAUGE, NY 11788-3605 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SELECTIVA GUIDEWIRE NEO METRICS, INC. 510(k) NO: K013024(TRADITIONAL) ATTN: GENE CHAMPEAU PHONE NO : 763-559-4440 15301 HIGHWAY 55 WEST SE DECISION MADE: 04-DEC-01 MINNEAPOLIS, MN 55447 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NICHOLS ADVANTAGE CHEMILUMINESCENCE BIO-INTACT PARATHYROID HORMO NICHOLS INSTITUTE DIAGNOSTICS 510(k) NO: K013992(TRADITIONAL) ATTN: ROBERT SCHMIDT PHONE NO : 949-240-5417 33051 CALLE AVIADOR SE DECISION MADE: 13-DEC-01 SAN JUAN CAPISTRANO, CA 92675 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: NICOLET ELECTROMAGNETIC NAVIGATION SYSTEM NICOLET VASCULAR, INC. 510(k) NO: K013419(TRADITIONAL) ATTN: DAVID W WAGNER PHONE NO : 303-431-9400 6355 JOYCE DR. SE DECISION MADE: 20-DEC-01 GOLDEN, CO 80403 510(k) STATEMENT DEVICE: NIPRO SAFELET CATH NIPRO MEDICAL CORP. 510(k) NO: K013287(TRADITIONAL) ATTN: KAELYN B HADLEY PHONE NO : 859-224-8256 1384 COPPERFIELD COURT SE DECISION MADE: 03-DEC-01 LEXINGTON, KY 40514 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NIPRO HYPODERMIC NEEDLE NIPRO MEDICAL CORP. 510(k) NO: K013293(TRADITIONAL) ATTN: KAELYN B HADLEY PHONE NO : 859-224-8256 1384 COPPERFIELD COURT SE DECISION MADE: 14-DEC-01 LEXINGTON, KY 40514 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOMOS MOTORIZED CRANE II NOMOS CORP. 510(k) NO: K013036(TRADITIONAL) ATTN: FRANCIS X DOBSCHA PHONE NO : 724-934-8242 2591 WEXFORD BAYNE RD., #400 SE DECISION MADE: 07-DEC-01 SEWICKLEY, PA 15143 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NORMATEC PCD NORMATEC, INC. 510(k) NO: K013436(TRADITIONAL) ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794 555 THIREENTH STREET SE DECISION MADE: 21-DEC-01 WASHINGTON, DC 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOMEDICS UV COLORS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LEN OCULAR SCIENCES PUERTO RICO, INC. 510(k) NO: K013377(TRADITIONAL) ATTN: RICHARD LIPPMAN PHONE NO : 301-770-9590 12300 TWINBROOK PARKWAY SE DECISION MADE: 20-DEC-01 SUITE 625 510(k) SUMMARY AVAILABLE FROM FDA ROCKVILLE, MD 20852 DEVICE: POLESTAR N-10 ODIN MEDICAL TECHNOLOGIES LTD. 510(k) NO: K010850(TRADITIONAL) ATTN: ADI ICKOWICZ PHONE NO : 972 495 91010 P.O. BOX 248 SE DECISION MADE: 17-DEC-01 YOKNEAM ELIT, ISRAEL 20692 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SONDREX P.A.L. SYSTEM OHMEDA MEDICAL 510(k) NO: K010388(TRADITIONAL) ATTN: ALBERTO F PROFUMO PHONE NO : 410-888-5204 8880 GORMAN RD. SE DECISION MADE: 11-DEC-01 LAUREL, MD 20723 510(k) STATEMENT DEVICE: HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE OLYMPUS AMERICA, INC. 510(k) NO: K013066(TRADITIONAL) ATTN: LAURA STORMS-TYLER PHONE NO : 631-844-5688 2 CORPORATE CENTER DR. SE DECISION MADE: 11-DEC-01 MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XENF-TP RHINO-LARYNGOFIBERSCOPE, ITS ACESSORIES AND ANCILLARY EQ OLYMPUS OPTICAL CO., LTD. 510(k) NO: K013591(TRADITIONAL) ATTN: LAURA STORMS-TYLER PHONE NO : 631-844-5688 TWO CORPORATE CENTER DRIVE SE DECISION MADE: 26-DEC-01 MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANISEIKONIA INSPECTOR OPTICAL DIAGNOSTICS, INC. 510(k) NO: K013110(TRADITIONAL) ATTN: JOYCE DE WIT PHONE NO : 425-391-9259 490 MT. FURY CIRCLE SW SE DECISION MADE: 19-DEC-01 ISSAQUAH, WA 98027 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12 RANGE VERIFIERS ORTHO-CLINICAL DIAGNOSTICS 510(k) NO: K013900(TRADITIONAL) ATTN: MARLENE A SHULMAN PHONE NO : 716-453-4041 100 INDIGO CREEK DRIVE SE DECISION MADE: 21-DEC-01 ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AVALON CUP SYSTEM ORTHOPEDIC SOURCE INC. 510(k) NO: K011887(TRADITIONAL) ATTN: STEVEN L MANDELL PHONE NO : 800-500-0381 PO BOX 307 SE DECISION MADE: 27-DEC-01 LOOMIS, CA 95650 510(k) STATEMENT DEVICE: ORTHOSONIX ENERGEX ORTHOSONIX, INC. 510(k) NO: K013094(TRADITIONAL) ATTN: RUSSELL PAGANO PHONE NO : 202-546-1266 615 7TH STREET NE SE DECISION MADE: 14-DEC-01 1ST FLOOR 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20002 DEVICE: MJS POSTERIOR STABILIZED KNEE SYSTEM OSTEOIMPLANT TECHNOLOGY, INC. 510(k) NO: K012762(TRADITIONAL) ATTN: SAM SON PHONE NO : 410-785-0700 11201 PEPPER RD. SE DECISION MADE: 11-DEC-01 HUNT VALLEY, MD 21031-1201 510(k) STATEMENT DEVICE: UBIT-IR300 INFRARED SPECTROMETRY SYSTEM OTSUKA PHARMACEUTICAL CO., LTD. 510(k) NO: K013371(TRADITIONAL) ATTN: CYNTHIA A SINCLAIR PHONE NO : 508-643-0434 49 PLAIN STREET SE DECISION MADE: 21-DEC-01 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OXOID PYLORI TEST KIT, MODEL DR0130M OXOID, LTD. 510(k) NO: K012588(TRADITIONAL) ATTN: ANDY HOLLINGSWORTH PHONE NO : 441 125 6841144 WADE ROAD SE DECISION MADE: 10-DEC-01 BASINGSTOKE,HANTS, UNITED KINGDOM 510(k) STATEMENT DEVICE: PALOMAR SLP 1000 PALOMAR MEDICAL PRODUCTS, INC. 510(k) NO: K013028(TRADITIONAL) ATTN: MARCY MOORE PHONE NO : 919-363-2432 131 KELEKENT LANE SE DECISION MADE: 06-DEC-01 CARY, NC 27511 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO: ABBOTT VASCULAR SUTURE ANASTOMOSIS DEVICE PERCLOSE, INC. 510(k) NO: K013683(SPECIAL) ATTN: PATTY HEVEY PHONE NO : 650-474-3202 400 SAGINAW SE DECISION MADE: 06-DEC-01 REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AT HOME DRUG TEST, MODEL 9084 PHAMATECH INC. 510(k) NO: K013407(SPECIAL) ATTN: CARL MONGIOVI PHONE NO : 858-635-5840 9530 PADGETT ST., #101-106 SE DECISION MADE: 06-DEC-01 SAN DIEGO, CA 92126 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AT HOME DRUG TEST, MODEL 9079 PHAMATECH INC. 510(k) NO: K013408(SPECIAL) ATTN: CARL MONGIOVI PHONE NO : 858-635-5840 9530 PADGETT ST., #101 SE DECISION MADE: 06-DEC-01 SAN DIEGO, CA 92126 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AT HOME DRUG TEST, MODEL 9074 PHAMATECH INC. 510(k) NO: K013409(SPECIAL) ATTN: CARL MONGIOVI PHONE NO : 858-635-5840 9530 PADGETT ST., #101 SE DECISION MADE: 06-DEC-01 SAN DIEGO, CA 92126 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AT HOME DRUG TEST, MODEL 9064 PHAMATECH INC. 510(k) NO: K013410(SPECIAL) ATTN: CARL MONGIOVI PHONE NO : 858-635-5840 9530 PADGETT ST., #101 SE DECISION MADE: 06-DEC-01 SAN DIEGO, CA 92126 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AT HOME DRUG TEST, MODEL 9069 PHAMATECH INC. 510(k) NO: K013412(SPECIAL) ATTN: CARL MONGIOVI PHONE NO : 858-635-5840 9530 PADGETT ST., #101 SE DECISION MADE: 06-DEC-01 SAN DIEGO, CA 92126 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTERA I/T PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K013344(TRADITIONAL) ATTN: PETER ALTMAN PHONE NO : 203-926-7031 472 WHEELERS FARMS ROAD SE DECISION MADE: 11-DEC-01 MILFORD, CT 06460 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO AGILENT COMPONENT MONITORING SYSTEM (CMS), V24/V PHILIPS MEDIZINSYSTEME BOBLINGEN G510(k) NO: K013624(SPECIAL) ATTN: DENISE HALEY PHONE NO : 978-687-1501 3000 MINUTEMAN ROAD SE DECISION MADE: 03-DEC-01 ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES PHOENIX DIAGNOSTICS, INC. 510(k) NO: K013451(TRADITIONAL) ATTN: RAM NUNNA PHONE NO : 508-655-8310 8 TECH CIRCLE SE DECISION MADE: 18-DEC-01 NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RT-PLUS KNEE ADDITIONAL COMPONENTS PLUS ORTHOPEDICS 510(k) NO: K013340(SPECIAL) ATTN: HARTMUT LOCH PHONE NO : 888-741-7587 6055 LUSK BLVD. SE DECISION MADE: 20-DEC-01 SAN DIEGO, CA 92121-2700 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOSCANNER PLUS POLYMER TECHNOLOGY SYSTEMS, INC. 510(k) NO: K014099(SPECIAL) ATTN: MARGO ENRIGHT PHONE NO : 317-870-5610 7736 ZIONSVILLE RD. SE DECISION MADE: 21-DEC-01 INDIANAPOLIS, IN 46268 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDPOR COATED TEAR DRAIN POREX SURGICAL, INC. 510(k) NO: K012108(TRADITIONAL) ATTN: HOWARD MERCER PHONE NO : 678-479-1610 15 DART RD. SE DECISION MADE: 19-DEC-01 NEWNAN, GA 30265 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDPOR PLUS SURGICAL IMPLANT BIOMATERIAL POREX SURGICAL, INC. 510(k) NO: K012350(TRADITIONAL) ATTN: HOWARD MERCER PHONE NO : 678-479-1610 15 DART RD. SE DECISION MADE: 05-DEC-01 NEWNAN, GA 30265 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP PORGES S.A. 510(k) NO: K013172(ABBREVIATED) ATTN: BERNARD ISMAEL PHONE NO : 331 460 13232 CENTRE D'AFFAIRES SE DECISION MADE: 20-DEC-01 LA BOURSIDIERE 510(k) SUMMARY AVAILABLE FROM FDA LE PLESSIS ROBINSON CEDEX, FRANCE DEVICE: REFERENCE CHECK, CATALOG NUMBER-RCN-10 PRECISION BIOLOGIC 510(k) NO: K013708(TRADITIONAL) ATTN: STEPHEN L DUFF PHONE NO : 902 468 6422 900 WINDMILL RD., SUITE 100 SE DECISION MADE: 10-DEC-01 DARTMOUTH, N.S., CANADA B3B 1P7 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PULPDENT CAVITY PREPARATION IV PULPDENT CORP. 510(k) NO: K013411(TRADITIONAL) ATTN: KENNETH J BERK PHONE NO : 617-926-6666 80 OAKLAND ST. SE DECISION MADE: 12-DEC-01 P.O. BOX 780 510(k) SUMMARY AVAILABLE FROM FDA WATERTOWN, MA 02471-0780 DEVICE: DYNAPULSE 5000A MINI ABP BLOOD PRESSURE MONITORING SYSTEM PULSE METRIC, INC. 510(k) NO: K013358(SPECIAL) ATTN: ROBERT DUFFY PHONE NO : 858-480-1171 11777 SORRENTO VALLEY ROAD SE DECISION MADE: 13-DEC-01 SAN DIEGO, CA 92121 510(k) STATEMENT DEVICE: RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), MOD RADI MEDICAL SYSTEMS AB 510(k) NO: K013943(SPECIAL) ATTN: MATS GRANLUND PHONE NO : 461 816 1000 PALMBLADSGATAN 10 SE DECISION MADE: 18-DEC-01 UPPSALA, SWEDEN S-754 50 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GENETRA RADIOMED CORPORATION 510(k) NO: K013660(SPECIAL) ATTN: GORDON ROBERTS PHONE NO : 978-649-0300 ONE INDUSTRIAL WAY SE DECISION MADE: 05-DEC-01 TYNGSBORO, MA 01879-1400 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XPLAN 2.2 WITH THE BODY SYSTEM RADIONICS, A DIVISION OF TYCO HEAL510(k) NO: K013661(SPECIAL) ATTN: KEVIN J O'CONNELL PHONE NO : 781-272-1233 22 TERRY AVE. SE DECISION MADE: 03-DEC-01 BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RANDOX PHENYTOIN RANDOX LABORATORIES, LTD. 510(k) NO: K011393(TRADITIONAL) ATTN: P. ARMSTRONG PHONE NO : 44 289 4422413 55 DIAMOND RD. SE DECISION MADE: 04-DEC-01 CRUMLIN, CO. ANTRIM, IRELAND BT29 510(k) STATEMENT DEVICE: REMINGTON PARAFFIN SPA, MODELS HS-200. PFS-600 REMINGTON PRODUCTS COMPANY, L.L.C.510(k) NO: K013328(TRADITIONAL) ATTN: PAMELA J FURMAN PHONE NO : 202-789-1212 1400 SIXTEENTH ST. N.W. SE DECISION MADE: 03-DEC-01 SUITE 400 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20036 DEVICE: RENMED CONTAMI-SHIELD BREATHING CIRCUIT SLEEVE, MODEL 9999/01 RENNELS MEDICAL CORP. 510(k) NO: K013200(TRADITIONAL) ATTN: DAVID LEE PHONE NO : 828-437-1085 PO BOX 3626 SE DECISION MADE: 14-DEC-01 MORGANTON, NC 28680-3626 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MISTER NEB NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS123 RESPIRONICS HEALTHSCAN, INC. 510(k) NO: K013027(TRADITIONAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 516-482-9001 55 NORTHERN BLVD., SE DECISION MADE: 06-DEC-01 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA GREAT NECK, NY 11021 THIRD PARTY REVIEW DEVICE: BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM RESPIRONICS, INC. 510(k) NO: K012323(SPECIAL) ATTN: DAVID J VANELLA PHONE NO : 724-733-5866 1001 MURRY RIDGE LANE SE DECISION MADE: 20-DEC-01 MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RAMP MYOGLOBIN ASSAY RESPONSE BIOMEDICAL CORP. 510(k) NO: K012040(TRADITIONAL) ATTN: WILLIAM J RADVAK PHONE NO : 604 681 4101 8855 NORTHBROOK COURT SE DECISION MADE: 18-DEC-01 BURNABY, BRITISH COLUMBIA, CANADA 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARDIOCOLLECT PORTABLE ELECTROCARDIOGRAPH REYNOLDS MEDICAL LTD. 510(k) NO: K013367(TRADITIONAL) ATTN: GEORGE MYERS PHONE NO : 201-727-1703 377 RT. 17 S. SE DECISION MADE: 13-DEC-01 HASBROUCK HEIGHTS, NJ 07604 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: METAPAK MULTI-PURPOSE INSTRUMENT TRAY RILEY MEDICAL, INC. 510(k) NO: K993535(TRADITIONAL) ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434 49 PLAIN STREET SE DECISION MADE: 07-DEC-01 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCU-CHEK ACTIVE TEST SYSTEM ROCHE DIAGNOSTICS CORP. 510(k) NO: K012324(TRADITIONAL) ATTN: MIKE FLIS PHONE NO : 800-428-5074 9115 HAGUE ROAD SE DECISION MADE: 05-DEC-01 P.O. BOX 50457 510(k) SUMMARY AVAILABLE FROM FDA INDIANAPOLIS, IN 46250-0457 DEVICE: ABUSCREEN ONLINE OPIATES 300 / 2000 ROCHE DIAGNOSTICS CORP. 510(k) NO: K013482(TRADITIONAL) ATTN: KERWIN KAUFMAN PHONE NO : 317-521-7637 9115 HAGUE RD. SE DECISION MADE: 21-DEC-01 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAS STREPALERT SA SCIENTIFIC, INC. 510(k) NO: K013379(TRADITIONAL) ATTN: RICARDO R MARTINEZ PHONE NO : 210-699-8800 4919 GOLDEN QUAIL SE DECISION MADE: 12-DEC-01 SAN ANTONIO, TX 78240 510(k) STATEMENT DEVICE: ULTRASAFE DENTAL INJECTION SYSTEM SAFETY SYRINGES, INC. 510(k) NO: K013801(SPECIAL) ATTN: THOMAS L HALL PHONE NO : 760-918-9908 1939 PALOMAR OAKS WAY, SUITE A SE DECISION MADE: 13-DEC-01 CARLSBAD, CA 92009 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY, MODEL 1-0101/1-010 SALIMETRICS LLC. 510(k) NO: K011323(TRADITIONAL) ATTN: EVE SCHWARTZ PHONE NO : 814-234-7748 101 INNOVATION BLVD. SE DECISION MADE: 17-DEC-01 SUITE 302 510(k) SUMMARY AVAILABLE FROM FDA STATE COLLEGE, PA 16803 DEVICE: SANYO CO2 INCUBATORS, MODELS NOS. MCO-17AC, MCO-17AIC, MCO-20AIC SANYO NORTH AMERICA CORP. 510(k) NO: K013703(TRADITIONAL) ATTN: SACHI KATAOKA PHONE NO : 630-875-3536 900 N. ARLINGTON HEIGHTS RD SE DECISION MADE: 14-DEC-01 SUITE 310 510(k) SUMMARY AVAILABLE FROM FDA TASCA, IL 60143-2844 DEVICE: SAUFLON MULTI LENS CARE SYSTEM SAUFLON PHARMACEUTICALS, LTD. 510(k) NO: K010559(TRADITIONAL) ATTN: LIGIA DELACRUZ PHONE NO : 440 208 3224200 49-53 YORK ST. SE DECISION MADE: 20-DEC-01 TWICKENHAM, MIDDLESEX, UNITED KING510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAUFLON 55 UV SOFT (HYDROPHILIC) CONTACT LENS SAUFLON PHARMACEUTICALS, LTD. 510(k) NO: K013649(TRADITIONAL) ATTN: LIGIA DELACRUZ PHONE NO : 442 083 224200 49-53 YORK ST. SE DECISION MADE: 26-DEC-01 TWICKENHAM, MIDDLESEX, UNITED KING510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NON-STERILE POWDER FREE GREEN LATEX EXAMINATION GLOVES WITH ALOE SGMP CO., LTD. 510(k) NO: K013288(TRADITIONAL) ATTN: JANNA TUCKER PHONE NO : 775-342-2612 198 AVENUE DE LA D'EMERALD SE DECISION MADE: 03-DEC-01 SPARKS, NV 89434 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CTS-415 SHANTOU INSTITUTE OF ULTRASONIC IN510(k) NO: K013327(TRADITIONAL) ATTN: BOB LEIKER PHONE NO : 925-556-1619 1106 CHILTERN DRIVE SE DECISION MADE: 14-DEC-01 WALNUT CREEK, CA 94596 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E SIEMENS ELEMA AB 510(k) NO: K010925(ABBREVIATED) ATTN: DIANE WURZBURGER PHONE NO : 732-321-4765 MEDICAL SOLUTIONS SE DECISION MADE: 18-DEC-01 186 WOOD AVENUE SOUTH 510(k) SUMMARY AVAILABLE FROM FDA ISELIN, NJ 08830-2770 DEVICE: MAGNETOM TRIO SYSTEM SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K013586(TRADITIONAL) ATTN: JAMIE YIEH PHONE NO : 732-321-4625 186 WOOD AVENUE SOUTH SE DECISION MADE: 28-DEC-01 ISELIN, NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971 SIGMA DIAGNOSTICS, INC. 510(k) NO: K013549(TRADITIONAL) ATTN: WILLIAM R GILBERT II PHONE NO : 314-286-6693 545 SOUTH EWING AVE. SE DECISION MADE: 26-DEC-01 ST. LOUIS, MO 63103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM SIMS LEVEL 1, INC. 510(k) NO: K011907(TRADITIONAL) ATTN: GABRIEL J MURACA, JR. PHONE NO : 781-878-8011 160 WEYMOUTH ST. SE DECISION MADE: 18-DEC-01 ROCKLAND, MA 02370 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GELCLAIR CONCENTRATED ORAL GEL SINCLAIR PHARMACEUTICALS, LTD. 510(k) NO: K013056(TRADITIONAL) ATTN: PRISCILLA COX PHONE NO : 44 166 3750410 1 ALDER BROOK SE DECISION MADE: 21-DEC-01 CHINLEY, HIGH PEAK, UNITED KINGDOM510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHOPHOS DS/DC CEPH, ORTHOPHOS 5/PLUS/CD SIRONA DENTAL SYSTEMS GMBH 510(k) NO: K013650(SPECIAL) ATTN: SHEILA M HEMEON-HEYER PHONE NO : 508-643-0434 49 PLAIN STREET SE DECISION MADE: 06-DEC-01 NORTH ATTLEBORO, MA 02760-4153 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM SIRONA DENTAL SYSTEMS GMBH 510(k) NO: K013659(SPECIAL) ATTN: SHEILA HEMEON-HEYER PHONE NO : 508-643-0434 49 PLAIN STREET SE DECISION MADE: 06-DEC-01 NORTH ATTLEBORO, MA 02760-4153 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERILE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CLAIM LES SMART GLOVE CORP. SDN BHD 510(k) NO: K013727(TRADITIONAL) ATTN: NG YEW SOON PHONE NO : 603 329 16100 LOT 6487 BATU 5 3/4 SE DECISION MADE: 07-DEC-01 JALAN KAPAR 510(k) STATEMENT KLANG SELANGOR, MALAYSIA 42100 DEVICE: 3D HUMERAL HEADS SMITH & NEPHEW, INC. 510(k) NO: K012378(TRADITIONAL) ATTN: DAVID HENLEY PHONE NO : 901-399-6487 1450 E. BROOKS ROAD SE DECISION MADE: 13-DEC-01 MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPON SMITH & NEPHEW, INC. 510(k) NO: K013658(SPECIAL) ATTN: DAVID HENLEY PHONE NO : 901-399-6487 1450 E. BROOKS ROAD SE DECISION MADE: 05-DEC-01 MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZIRCONIA CERAMIC FEMORAL HEAD - 12/14 TAPER SMITH & NEPHEW, INC. 510(k) NO: K013989(SPECIAL) ATTN: JANET JOHNSON GREEN PHONE NO : 901-399-5153 1450 E. BROOKS ROAD SE DECISION MADE: 19-DEC-01 MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GLO-SPEC SOL WEISS MD INC 510(k) NO: K013817(TRADITIONAL) ATTN: SOL WEISS PHONE NO : 818-346-1515 7012 RESEDA BOULEVARD SE DECISION MADE: 21-DEC-01 SUITE A 510(k) SUMMARY AVAILABLE FROM FDA RESEDA, CA 91335 DEVICE: HAND-CARRIED ULTRASOUND SYSTEM SONOSITE,INC. 510(k) NO: K014116(TRADITIONAL) ATTN: MICHAEL HOFFMAN PHONE NO : 425-951-1297 21919 30TH DRIVE SE. SE DECISION MADE: 20-DEC-01 BOTHELL, WA 98021-3904 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SOPRO 67D OPERATING ROOM CAMERA SOPRO 510(k) NO: K013090(TRADITIONAL) ATTN: PIERRE MONTILLOT PHONE NO : 334 912 70727 PLACE ST. CHRISTOPHE SE DECISION MADE: 13-DEC-01 LES ACCATES-LA VALENTINE 510(k) STATEMENT MARSEILLE, FRANCE F-13011 DEVICE: TRIMAX STANDARD TEXTILE CO., INC. 510(k) NO: K012268(TRADITIONAL) ATTN: BRADLEY J BUSHMAN PHONE NO : 513-761-9255 ONE KNOLLCREST DR. SE DECISION MADE: 03-DEC-01 P.O. BOX 371805 510(k) SUMMARY AVAILABLE FROM FDA CINCINNATI, OH 45237-1600 DEVICE: STELLARTECH COAGULATION SYSTEM STELLARTECH RESEARCH CORP. 510(k) NO: K013139(TRADITIONAL) ATTN: JAMES R SANTOS PHONE NO : 408-331-3000 1346 BORDEAUX DR. SE DECISION MADE: 18-DEC-01 SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ISITE RADIOLOGY STENTOR, INC. 510(k) NO: K013630(TRADITIONAL) ATTN: GARY J ALLSEBROOK PHONE NO : 510-276-2648 16303 PANORAMIC WAY SE DECISION MADE: 05-DEC-01 SAN LEANDRO, CA 94578 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM STERIS CORP. 510(k) NO: K013242(ABBREVIATED) ATTN: ROBERT H MCCALL PHONE NO : 334-213-3150 2720 GUNTER PARK DRIVE EAST SE DECISION MADE: 13-DEC-01 MONTGOMERY, AL 36109 510(k) STATEMENT DEVICE: SIMPLICITY CLASSIC WING QD INFUSION SET STERLING MEDIVATIONS, INC. 510(k) NO: K013502(ABBREVIATED) ATTN: JOEL DOUGLAS PHONE NO : 650-949-0470 25285 LA LOMA DR. SE DECISION MADE: 03-DEC-01 LOS ALTOS HILLS, CA 94022-4583 510(k) STATEMENT DEVICE: SIMPLICITY INFUSION RESERVOIR FOR USE TO INFUSE MEDICINE, INCLUD STERLING MEDIVATIONS, INC. 510(k) NO: K013767(TRADITIONAL) ATTN: JOEL DOUGLAS PHONE NO : 650-814-4083 25285 LA LOMA DR. SE DECISION MADE: 12-DEC-01 LOS ALTOS HILLS, CA 94022-4583 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRYKER PAINPUMP STRYKER CORP. 510(k) NO: K014091(SPECIAL) ATTN: NICOLE PETTY PHONE NO : 616-323-7700 4100 E. MILHAM AVENUE SE DECISION MADE: 31-DEC-01 KALAMAZOO, MI 49001 510(k) STATEMENT DEVICE: MODIFICATION TO: STRYKER NAVIGATION SYSTEM, STRYKER FLUOROSCOPY STRYKER LEIBINGER 510(k) NO: K012380(TRADITIONAL) ATTN: ROBIN L ROWE PHONE NO : 616-323-7700 4100 EAST MILHAM AVE SE DECISION MADE: 03-DEC-01 KALAMAZOO, MI 49001 510(k) STATEMENT DEVICE: MOST OPTIONS SYSTEM SULZER ORTHOPEDICS, INC. 510(k) NO: K013031(TRADITIONAL) ATTN: FRANCES E HARRISON PHONE NO : 512-432-9306 9900 SPECTRUM DR. SE DECISION MADE: 07-DEC-01 AUSTIN, TX 78717 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALLOFIT ACETABULAR SYSTEM 32MM ALPHA DURASUL INSERTS SULZER ORTHOPEDICS, INC. 510(k) NO: K013935(SPECIAL) ATTN: MITCHELL A DHORITY PHONE NO : 512-432-9202 9900 SPECTRUM DRIVE SE DECISION MADE: 13-DEC-01 AUSTIN, TX 78717 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIGN IM NAIL SURGICAL IMPLANT GENERATION NETWOR510(k) NO: K013132(TRADITIONAL) ATTN: DOUG DONNELLY PHONE NO : 509-371-1107 2950 GEORGE WASHINGTON WAY SE DECISION MADE: 20-DEC-01 RICHLAND, WA 99352-1615 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRIZM KERATOME BLADE (NIDEK MODEL), MODEL MK8514NI SURGIN INC 510(k) NO: K013337(TRADITIONAL) ATTN: DON HAAR PHONE NO : 714-832-6300 14762 BENTLEY CIRCLE SE DECISION MADE: 13-DEC-01 TUSTIN, CA 92780 510(k) STATEMENT DEVICE: AURIS AEP SYNAPSYS, INC. 510(k) NO: K012415(TRADITIONAL) ATTN: JULIEN CHAUSSY PHONE NO : 718-525-3376 150-10 132 AVENUE SE DECISION MADE: 18-DEC-01 JAMAICA, NY 11434 510(k) STATEMENT DEVICE: NORIAN SRS BONE VOID FILLER SYNTHES (USA) 510(k) NO: K011897(TRADITIONAL) ATTN: ANGELA J SILVESTRI PHONE NO : 610-647-9700 1690 RUSSELL RD. SE DECISION MADE: 20-DEC-01 PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES 2.4 MM CANNULATED SCREW SYNTHES (USA) 510(k) NO: K012945(TRADITIONAL) ATTN: MATTHEW M HULL PHONE NO : 610-647-9700 1690 RUSSELL RD. SE DECISION MADE: 03-DEC-01 PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES 3.9 MM PELVIC SCREWS SYNTHES (USA) 510(k) NO: K013044(TRADITIONAL) ATTN: MATTHEW M HULL PHONE NO : 610-647-9700 1690 RUSSELL RD. SE DECISION MADE: 03-DEC-01 PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES LCP DISTAL TIBIA PLATES SYNTHES (USA) 510(k) NO: K013248(TRADITIONAL) ATTN: MATTHEW M HULL PHONE NO : 610-647-9700 P.O. BOX 1766 SE DECISION MADE: 19-DEC-01 1690 RUSSELL ROAD 510(k) SUMMARY AVAILABLE FROM FDA PAOLI, PA 19301-1222 DEVICE: MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) S SYNTHES (USA) 510(k) NO: K013527(SPECIAL) ATTN: BONNIE J SMITH PHONE NO : 610-647-9700 1690 RUSSELL RD. SE DECISION MADE: 21-DEC-01 PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TCI-31 LIFELONG OVULATION TESTER TCI NEW YORK 510(k) NO: K013323(TRADITIONAL) ATTN: ERIKA B AMMIRATI PHONE NO : 650-949-2768 575 SHIRLYNN COURT SE DECISION MADE: 05-DEC-01 LOS ALTOS, CA 94022 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TEKMEDIC POWDER-FREE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS TEKMEDIC (M) SDN BHD 510(k) NO: K013317(TRADITIONAL) ATTN: KOK-KEE HON PHONE NO : 703-941-7656 P.O. BOX 11112 SE DECISION MADE: 17-DEC-01 ALEXANDRIA, VA 22312-9998 510(k) STATEMENT DEVICE: CAPIOX SX10 HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESER TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K010443(TRADITIONAL) ATTN: GARRY A COURTNEY PHONE NO : 800-283-7866 125 BLUE BALL ROAD SE DECISION MADE: 11-DEC-01 ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TETRAD MODEL TC-EC7-ACP, -L5-, -L7-, -V4-ACP TRANSDUCERS TETRAD CORP. 510(k) NO: K013849(TRADITIONAL) ATTN: CHARLES F HOTTINGER PHONE NO : 408-741-1006 357 INVERNESS DR. SOUTH, SE DECISION MADE: 03-DEC-01 SUITE A 510(k) SUMMARY AVAILABLE FROM FDA ENGLEWOOD, CO 80112 THIRD PARTY REVIEW DEVICE: MODIFICATION TO BLOOD GLUCOSE MONITORING SYSTEM THERASENSE, INC. 510(k) NO: K012014(TRADITIONAL) ATTN: EVE A CONNER PHONE NO : 510-749-5400 1360 SOUTH LOOP ROAD SE DECISION MADE: 05-DEC-01 ALAMEDA, CA 94502-7000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AIA-PACK CTNI 2ND-GEN ASSAY TOSOH MEDICS, INC. 510(k) NO: K012820(TRADITIONAL) ATTN: LOIS NAKAYAMA PHONE NO : 650-615-4970 347 OYSTER POINT BLVD., SE DECISION MADE: 14-DEC-01 SUITE 201 510(k) STATEMENT SOUTH SAN FRANCISCO, CA 94080 DEVICE: SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPT TREK DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K013580(TRADITIONAL) ATTN: CYNTHIA C KNAPP PHONE NO : 800-216-9036 29299 CLEMENS RD., SUITE 1-K SE DECISION MADE: 12-DEC-01 WESTLAKE, OH 44145 510(k) STATEMENT DEVICE: SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPT TREK DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K013925(TRADITIONAL) ATTN: CYNTHIA C KNAPP PHONE NO : 800-216-9036 29299 CLEMENS RD., SUITE 1-K SE DECISION MADE: 21-DEC-01 WESTLAKE, OH 44145 510(k) STATEMENT DEVICE: HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED, VERSION 2 TRIAD MEDICAL, INC. 510(k) NO: K013903(SPECIAL) ATTN: RITA GIEBEL PHONE NO : 949-262-0411 3722 AVE. SAUSALITO SE DECISION MADE: 17-DEC-01 IRVINE, CA 92606 510(k) STATEMENT DEVICE: WET LIGHT PERSONAL MOISTURIZER TRIGG LABORATORIES, INC. 510(k) NO: K013086(TRADITIONAL) ATTN: W. PATRICK NOONAN PHONE NO : 818-887-5600 WARNER CENTER PLAZA SE DECISION MADE: 13-DEC-01 21800 OXNARD STREET, SUITE 840 510(k) STATEMENT WOODLAND HILLS, CA 91367 DEVICE: DIGIPAN / DPI TROPHY RADIOLOGIE 510(k) NO: K012514(TRADITIONAL) ATTN: MARIE-PIERRE LABAT-CAMY PHONE NO : 331 648 08500 4 RUE F. PELLOUTIER CROISSY SE DECISION MADE: 21-DEC-01 BEAUBOURG 510(k) STATEMENT MARNE LA VALLEE CEDEX 2, FRANCE 77437 DEVICE: MONOJECT PREFILL HEPARIN LOCK FLUSH SYRINGE TYCO HEALTHCARE 510(k) NO: K013556(TRADITIONAL) ATTN: DAVID A OLSON PHONE NO : 508-261-8000 15 HAMPSHIRE STREET SE DECISION MADE: 31-DEC-01 MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENT LASERVISION UNION MEDICAL USA 510(k) NO: K012071(TRADITIONAL) ATTN: ANNIE VELEZ PHONE NO : 305-629-9339 3750 NW 114TH AVENUE SE DECISION MADE: 03-DEC-01 UNIT #5 510(k) STATEMENT MIAMI, FL 33178 DEVICE: AUTO SUTURE SURGICAL STAPLES UNITED STATES SURGICAL, A DIVISION510(k) NO: K013860(SPECIAL) ATTN: CHESTER MCCOY PHONE NO : 203-845-1390 150 GLOVER AVE. SE DECISION MADE: 19-DEC-01 NORWALK, CT 06856 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURGICAL DYNAMICS MENISCAL STAPLE UNITED STATES SURGICAL, A DIVISION510(k) NO: K013890(SPECIAL) ATTN: JENNIFER SCHUCK PHONE NO : 203-845-4512 150 GLOVER AVE. SE DECISION MADE: 11-DEC-01 NORWALK, CT 06856 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NURVO 9000 ENDOCAVITARY COILS USA INSTRUMENTS, INC. 510(k) NO: K011683(TRADITIONAL) ATTN: RONY THOMAS PHONE NO : 330-562-1000 1515 DANNER DRIVE SE DECISION MADE: 10-DEC-01 AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRYSTAL 5000 PHASES ARRAY TMJ COIL USA INSTRUMENTS, INC. 510(k) NO: K013528(TRADITIONAL) ATTN: RONY THOMAS PHONE NO : 330-562-1000 1515 DANNER DRIVE SE DECISION MADE: 13-DEC-01 AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SHOULDER COIL USA INSTRUMENTS, INC. 510(k) NO: K013541(TRADITIONAL) ATTN: RONY THOMAS PHONE NO : 330-562-1000 1515 DANNER DRIVE SE DECISION MADE: 14-DEC-01 AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VANGUARD REPROCESSED FEMORAL COMPRESSION DEVICE VANGUARD MEDICAL CONCEPTS, INC. 510(k) NO: K011832(TRADITIONAL) ATTN: MIKE SAMMON PHONE NO : 863-683-8680 5307 GREAT OAK DR. SE DECISION MADE: 21-DEC-01 LAKELAND, FL 33815 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GELBISH VASCULAR DILATOR VASCUMETRIX, LLC 510(k) NO: K012256(TRADITIONAL) ATTN: MIKE HAMMONS PHONE NO : 480-807-6300 2824 N. POWER RD. SE DECISION MADE: 20-DEC-01 SUITE 113-278 510(k) SUMMARY AVAILABLE FROM FDA MEAS, AZ 85215-1674 DEVICE: VENTLAB HYPERINFLATION BAG SYSTEM VENTLAB CORP. 510(k) NO: K013308(TRADITIONAL) ATTN: MARGE WALLS-WALKER PHONE NO : 336-492-2636 2934 HWY. 601 NORTH SE DECISION MADE: 20-DEC-01 MOCKSVILLE, NC 27028 510(k) STATEMENT DEVICE: VERTIS PNT CONTROL UNIT, VERTIS PNT SAFEGUIDE KIDS, MODELS CU100 VERTIS NEUROSCIENCE, INC. 510(k) NO: K011702(TRADITIONAL) ATTN: LORI GLASTETTER PHONE NO : 206-902-1902 2101 FOURTH AVE STE 200 SE DECISION MADE: 21-DEC-01 SEATTLE, WA 98121-2329 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIATRONIC V3D CALCIUM SCORING VIATRONIX, INC. 510(k) NO: K013146(TRADITIONAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 516-482-9001 55 NORTHERN BLVD. SE DECISION MADE: 07-DEC-01 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA GREAT NECK, NY 11021 DEVICE: VICTORCH MEDITEK'S HCG TEST CARD VICTORCH MEDITEK, INC. 510(k) NO: K013678(TRADITIONAL) ATTN: PIERCE LIU PHONE NO : 858-530-9191 7313 CARROLL RD., SUITE A-B SE DECISION MADE: 27-DEC-01 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: VICTORCH HCG TEST STRIP VICTORCH MEDITEK, INC. 510(k) NO: K013702(TRADITIONAL) ATTN: PIERCE LIU PHONE NO : 858-530-9191 7313 CARROLL RD., SUITE A-B SE DECISION MADE: 27-DEC-01 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: RF GENERATORS, DISPOSABLE CARTRIDGE KIT, DISPOSABLE CARTRIDGE, R VIDAMED, INC. 510(k) NO: K012587(TRADITIONAL) ATTN: YI CHEN PHONE NO : 510-492-4934 46107 LANDING PKWY. SE DECISION MADE: 11-DEC-01 FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GORE INTRODUCER SHEATH W. L. GORE & ASSOCIATES, INC. 510(k) NO: K013282(TRADITIONAL) ATTN: R. LARRY PRATT PHONE NO : 928-779-2771 3450 WEST KLINE LANE SE DECISION MADE: 14-DEC-01 P.O. BOX 500 510(k) SUMMARY AVAILABLE FROM FDA FLAGSTAFF, AZ 86002-0500 DEVICE: GORE DRAPEABLE ST/LT REGENERATIVE MEMBRANE W.L. GORE & ASSOCIATES,INC 510(k) NO: K013346(TRADITIONAL) ATTN: JACQUELINE KALBACH PHONE NO : 928-864-3731 3450 KILTIE LANE SE DECISION MADE: 19-DEC-01 P.O. BOX 500 510(k) SUMMARY AVAILABLE FROM FDA FLAGSTAFF, AZ 86002-0500 DEVICE: AUROPAL, ORDER-NO.: 2101 WIELAND EDELMETALLE GMBH & CO. 510(k) NO: K012839(TRADITIONAL) ATTN: GERHARD P0LZER PHONE NO : 49 723 13705219 SCHWENNINGER STRABE 13 SE DECISION MADE: 31-DEC-01 D-75179 PFORZHEIM, GERMANY 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WIENER LAB. GLICEMIA ENZIMATICA AA MODELS 1 X 250 ML CAT. #14001 WIENER LABORATORIES S.A.I.C. 510(k) NO: K011953(TRADITIONAL) ATTN: VIVIANA CETOLA PHONE NO : 543 414 329191 2944 RIOBAMBA SE DECISION MADE: 21-DEC-01 ROSARIO, ARGENTINA 2000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WIENER LAB. CA-COLOR AA, MODEL 4 X 50 ML CAT.N 1152002 WIENER LABORATORIES S.A.I.C. 510(k) NO: K013652(TRADITIONAL) ATTN: VIVIANA CETOLA PHONE NO : 543 414 329191 2944 RIOBAMBA SE DECISION MADE: 21-DEC-01 ROSARIO, ARGENTINA 2000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GUARDIAN LIMB SALVAGE SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K013035(TRADITIONAL) ATTN: EHAB M ESMAIL PHONE NO : 901-867-4457 5677 AIRLINE RD. SE DECISION MADE: 07-DEC-01 ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE BLUE LATEX EXAMINATION GLOVE, NON-STERILE (PROTEIN C WRP SPECIALTY PRODUCTS SDN. BHD. 510(k) NO: K013942(TRADITIONAL) ATTN: MOHD H HUSSEIN PHONE NO : 603 870 69788 LOT11 JALAN2 PERUSAHAAN BANDAR SE DECISION MADE: 31-DEC-01 KAWASAN BARU SALAK TINGGI 510(k) SUMMARY AVAILABLE FROM FDA SEPANG, SELANGOR, MALAYSIA 43900 DEVICE: ZEUS SCIENTIFIC, INC. ATHENA MULTI-LYTE ANA TEST SYSTEM ZEUS SCIENTIFIC, INC. 510(k) NO: K011244(TRADITIONAL) ATTN: MARK J KOPNITSKY PHONE NO : 908-526-3744 P.O. BOX 38 SE DECISION MADE: 10-DEC-01 RARITAN, NJ 08869 510(k) STATEMENT DEVICE: PROLONG HIGHLY CROSSLINKED POLYETHTYLENE CRUCIATE RETAINING (CR) ZIMMER, INC. 510(k) NO: K013991(SPECIAL) ATTN: STEPHEN H MCKELVEY PHONE NO : 219-372-4944 P.O. BOX 708 SE DECISION MADE: 27-DEC-01 WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 286 TOTAL WITH SUMMARIES 232 TOTAL WITH STATEMENTS 54
Updated 11/26/02
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